Type II Diabetes Mellitus Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomised, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KBP-089 in Patients With Type II Diabetes
KeyBioscience is developing KBP-089, a dual activator of both the amylin and calcitonin
receptors, for the treatment of type II diabetes mellitus, using a subcutaneous injectable
mode of administration.
This is a double-blind, placebo-controlled, randomised, multiple-ascending dose phase I trial
to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of
KBP-089 in patients with type 2 diabetes, who are on stable therapy with metformin.
Subjects will receive daily subcutaneous injections in the abdomen over a period of 28 days.
The planned maximum doses of KBP-089 to be investigated in the trial are 20 µg in cohort 1,
60 µg in cohort 2, and 150 µg in cohort 3. For cohort 1, the dose is planned to be escalated
every 7 ±1 days, and for cohort 2 and cohort 3, every 3 days. Doses may be modified according
to individual tolerability, but the dose regimen will not exceed 28 days.
The IMP is administered by daily subcutaneous injections taken in the morning before
breakfast.
The trial is performed in Germany and at least 36 patients will be enrolled in the trial. The
trial will be randomised 1:1:1 between maximum doses of KBP-089 of 20 µg, 60 µg, 150 µg and
placebo. Within each of the three cohorts, 12 patients will be randomised 3:1 to KBP-089 and
placebo.
n/a
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